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OS Therapies Achieves FDA And UK MHRA Alignment On Design Of Its Pending Phase 3 Study Of OST-HER2 For Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma

Benzinga·06/08/2026 10:08:40
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  • Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia
  • Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint
  • TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3
  • FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC)
  • Market access process initiated with UK NICE and EU JCA